VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE. IT WAS MENTIONED THAT WHEN THE DEVICE WAS PREPARED WITH THE DOUBLE CURVE SHEATH, THE SHEATH AND DILATOR TIP WAS NOTED DAMAGED. THUS THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS. IT WAS FURTHER CONFIRMED THAT DILATOR WAS NOT LOADED ON THE WIRE. THE DEVICE NEVER WENT INTO THE BODY, IT WAS NOTED DURING PREPARATION. THE CONNECT DILATOR WAS THE DBL CURVE WAS COMING APART.